DEVICE: Deltex Medical CardioQ EDM (05055679404319)

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Device Identifier (DI) Information

Deltex Medical CardioQ EDM
9051-7057

DELTEX MEDICAL LIMITED
05055679404319
GS1
1
The CardioQ EDM is intended for use as a fluid management and cardiac output monitoring system. The system is designed to provide clinicians with real-time information about left-ventricular blood flow.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Transoesophageal vascular ultrasound monitor A mains electricity (AC-powered) device intended to be used for monitoring cardiac output and/or fluid status through connection to a dedicated probe, which is placed in the oesophagus to measure blood flow in the descending aorta. It is based on measuring the ultrasonic frequency shift between transmitted and reflected signals (Doppler principle) and is displayed on the monitor as a velocity/time waveform. It is typically used during a surgical procedure or in intensive care.
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FDA Product Code

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Product Code Product Code Name
DPW Flowmeter, Blood, Cardiovascular
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 0 and 40 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 07, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
5055679406108 1 05055679404319 In Commercial Distribution Cardboard Box
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
Yes
No
Yes
No CLOSE

Customer Contact

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+4401243774837
customer.services@deltexmedical.com
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